False doubts about breast implants

by Jeff JacobyThe Boston Globe
June 23, 1994

http://www.jeffjacoby.com/1792/false-doubts-about-breast-implants

TWO YEARS AGO, the Food and Drug Administration stomped on the freedom of women, insulted their doctors' competence, and let itself be swayed by junk science peddled by scaremongering lawyers. The almost total ban imposed by the FDA on silicone-gel breast implants in April 1992 was more than arrogant and paternalistic. It was based explicitly on the belief that American women were not fit to decide for themselves whether breast implants were right for them.

"It has become fashionable in some quarters" -- the contempt that oozed through FDA Commissioner David Kessler's explanation for the ban was unmistakable -- "to argue that women ought to be able to make such decisions on their own." How trendy. "If members of our society were empowered to make their own decisions . . .," he objected, "then the whole rationale for the agency would cease to exist." Never mind women's health, this was about bureaucratic self-preservation.

Vainly, medical professionals pointed out that breast implants were not some untested innovation. They had been available in the United States since 1963, and as many as 2 million women had opted for them. By the early 1990s, breast implants had become the second-most common form of plastic surgery, with 150,000 women a year choosing the procedure. Some of these women wanted implants for breast reconstruction following a mastectomy. But the vast majority, 80 percent, wanted to enlarge their breasts for cosmetic reasons.

Feminists can argue over how concerned women should be with the size and shape of their bodies. What is unarguable is that over the course of three decades, nearly all women who had breast enlargements were pleased with the results. A national survey undertaken in 1990 by the American Society of Plastic and Reconstructive Surgeons found that more than 90 percent of women who had gotten implants remained happy with their decision.

When he yanked silicone implants from the market, Kessler didn't claim they were dangerous. Rather, he objected that manufacturers had not submitted enough data on the issue, so there were still "unanswered questions about their safety." But the reason scientists weren't devoting more resources to scrutinizing the risks of breast implants is that 30 years of experience -- not in the laboratory but in real life -- had already shown them to be harmless, durable, and effective.

The impact of the FDA's ban was explosive. Women with implants were frightened into thinking the government had pronounced them dangerous. Alarming stories linking implants to painful diseases swept the land. Ambulance-chasing lawyers and Naderite "advocates" began hyping the fears and exaggerating the (unproven) risks. Lawsuits were filed. Plaintiffs hit the TV talk shows. Juries started returning million-dollar verdicts. New lawsuits followed. And more hype, and more panic. Your tax dollars at work.

Eventually the manufacturers succumbed. Battered in the media and in court, they agreed to a class-action settlement of $ 4.2 billion. Thanks to the FDA, the lawyers will clean up nicely.

But the truth hadn't changed: Breast implants are safe. And now comes The New England Journal of Medicine to reconfirm that truth. In the journal's current issue, Dr. Sherine Gabriel and five of her colleagues at the Mayo Clinic publish the results of the most complete study ever done on the dangers of silicone implants. Bottom line: There are no dangers, or at least none they could find.

The study, which scoured the medical records of more than 2,200 women over an average of eight years each, is called "Risk of Connective-Tissue Diseases and Other Disorders After Breast Implantation" -- not the jazziest title, granted. As you might expect, the paper is filled with scientific jargon. But you don't have to be an MD to understand the doctors' bottom line: "We found no association between breast implants and the connective-tissue diseases and other disorders that were studied."

The authors acknowledge that their study isn't the definitive last word. If they could analyze the medical histories of a couple of hundred thousand women, they write, they could conclusively nail down the implant-related risks of even the rarest diseases.

Modesty is always becoming (especially in doctors), but for all practical purposes, the issue is settled. Breast implants do not pose a danger to women.

The same cannot be said of the FDA. Where were feminists -- many of whom argue hotly that a woman should be free to choose an abortion -- when the government slammed the door shut on a woman's freedom to choose this procedure? Where were other women? For that matter, where were men?

The FDA banned a straightforward procedure that has brought self-esteem, peace of mind, or satisfaction to a great number of women. You don't understand how implants can enhance the quality of life for a woman unhappy with her shape? Substitute hair weaves for men who have lost their hair. Or dermabrasion for those with pockmarked skin. Or contact lenses for the weak-eyed. Kessler's ban was an outrage in 1992, and it is even more of one today. One premise of American freedom is that men and women can make rational assessments of risks and benefits, and order their lives accordingly. Big Brother does not know best.